# K221144: Pedra-1417MC, Pedra-1417MG, Pedra-1417FC, Pedra-1417FG

- Pathway: 510(k) (Special)
- Applicant: Radisen Co., Ltd.
- Decided: May 13, 2022 after 23 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K180989 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180989: PEDRA-17F Digital Flat Panel X-ray Detector, Radisen, Inc. (2018) Summary page 4.

## Indications for use
The PEDRA Digital Flat Panel X-ray detector is indicated as a digital imaging solution designed for the general radiographic system for human anatomy. It is intended to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures. It is not to be used for mammography.

Source page: https://510kreport.com/device/K221144
Methodology: https://510kreport.com/methodology